In Pakistan, a smartphone app will help lay health workers deliver cognitive behavioural therapy to pregnant women with depression. Perinatal depression affects roughly one in four women in South Asia, yet most go untreated because health systems lack specialist supervisors to oversee psychological therapy. The Thinking Healthy Programme—a World Health Organisation-approved, culturally adapted intervention—works, but cannot scale without a way to support non-specialist therapists. This project builds a digital application using human-centred design, then tests it in a cluster randomised trial across 40 villages with 560 women. The app guides lay-therapists through therapy sessions, tracks patient progress, and flags problems, replacing the need for scarce expert supervisors. If the app proves effective and cost-effective, it could allow Pakistan’s Ministry of Health to roll out the Thinking Healthy Programme nationally. The World Health Organisation would also incorporate findings into its global mental health gap action programme, potentially enabling other low-income countries to treat perinatal depression at scale without building specialist workforces first. The project simultaneously trains early-career researchers in Nepal, Bangladesh, and Sri Lanka to adapt the approach for their own health systems.
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Background Perinatal depression affects about one in 4 women in South Asia and has huge human and economic costs. Effective and culturally adapted psychological interventions are available but the vast majority remain untreated because of overburdened health systems and lack of specialist supervisors. Digital technologies are increasingly being used in many areas of health care, but there is no Application that can assist lay-therapists to deliver an evidence-based intervention effectively in low-income settings. Aims and objectives We aim to: a) Develop and evaluate a digital Application (App) to facilitate delivery of a World Health Organisation-approved Cognitive Therapy based intervention, the Thinking Healthy Programme, through lay-therapists in Pakistan. b) Build implementation research capacity in 4 South Asian countries, Pakistan, Nepal, Bangladesh and Sri Lanka, to facilitate scale-up of the intervention in their settings. Methods The research component will be carried out in Pakistan in two phases: a) Formative phase (18 months): We already have extensive knowledge of the content, methods of training, supervision and delivery of the Thinking Healthy Programme which was developed by our team. Building on this knowledge, we will develop the App employing a Human-Centred Design, which places end-users at the heart of the process in 3 iterative steps: i) identifying the requirements of lay-therapists and mothers through in-depth interviews and focus group discussions; ii) testing multiple prototypes on selected users, and; iii) testing the final prototype in actual conditions. b) Evaluation phase (30 months): We will then compare the effectiveness and cost-effectiveness of the App-assisted intervention with enhanced usual care using a cluster randomised control trial (cRCT) design. We will randomly assign 40 village clusters (1:1) to provide the App-assisted Thinking Healthy Programme or Enhanced Usual Care (control group) to the participants within clusters. The participants will be pregnant women aged 18 years or older who score at least 10 on the Patient Health Questionnaire-9 (PHQ-9). The sample size will be 560 women. Participants will be evaluated at 3 and 6 months after childbirth. The primary outcomes will be the severity of depressive symptoms (assessed by PHQ-9 score) and the prevalence of remission (defined as a PHQ-9 score of less than 5) 3 months after childbirth, assessed by researchers masked to treatment allocations. Outcomes will be analysed by intention to treat, adjusting for covariates that will be defined a priori. The capacity building component will operate in the 3 collaborating countries (Nepal, Bangladesh, Sri Lanka) through a Research Fellowship scheme for early career researchers. They will be trained to undertake research projects in areas which are thought to be critical for implementation in their respective countries. Anticipated impact and Dissemination In Pakistan, we are working closely with the Ministry of Health to scale-up the Thinking Healthy programme nationally. The research will feed directly into this national programme. Globally, we will work closely with the World Health Organization to incorporate our findings into the revised version of the Thinking Healthy Programme which will be disseminated to all member countries through the WHO s flagship mental health gap action programme.
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